by Seth J. Baum MD

I was fortunate to have the opportunity to speak at length with Matt Perrone prior to his submitting an April 20th article on the PSCK9 inhibitors’ unexpectedly low uptake in the medical community. His piece was excellent; yet it failed to address the most salient aspect of this problem: Patients are suffering.

As I stated in my March 21st article on the same topic, the basis for the paucity of patients using these medications is not physicians’ reluctance to prescribe, or their need for outcomes data, or even their inappropriate utilization of these treatments. Instead, insurance providers are blocking patients’ access. This is what accounts for the small number of people currently taking PCSK9 inhibitors.

Consider this: A 90% denial rate for PCSK9 inhibitor prescriptions has been documented. This is unprecedented. Do so many physicians fail to understand the simple FDA prescribing recommendations? ‘Familial hypercholesterolemia or clinical ASCVD requiring greater LDL reduction on maximally tolerated statin therapy’: These are the irrefutably straightforward criteria required for doctors to prescribe. Trust me; this is easy. Any clinician worth his or her salt can follow these instructions. Yet, 90% of prescriptions are being denied. I repeat the statistic, as it is both stunning and distressing. And whom do you think suffers the consequences? Certainly it is not the insurers who through their denials do not have to pay for the medications. It’s the patients of course. The patients with life-threatening coronary artery disease or familial hypercholesterolemia are the ones in jeopardy. These are atherosclerotic-besieged patients in whom time truly is plaque. And plaque begets heart attacks, strokes, and even death. So by forcing a protracted review process (often many months) inappropriate denials may in essence be putting patients’ lives in harm’s way.

Nevertheless, if you are a patient in need, please do not surrender.  Even though challenges will surely arise, have faith that you are being supported. While doctors and patient advocacy groups struggle to obtain fairness in this realm, let me share some suggestions that you, the patients requiring such remedies, can do to help yourselves:
1.    Be your own advocate. If you and your doctor decide that a PCSK9 inhibitor is indicated and your insurance company denies the prescription; do not capitulate. Instead, review your policy’s drug formulary. If a PCSK9 inhibitor is listed, and it has been deemed medically indicated by your doctor, you are guaranteed access to the drug. This cannot be denied you.
2.    Next, contact the insurance company and demand treatment. If you are again denied therapy, move to step 3.
3.    Contact your state’s insurance commissioner.
4.    Then, call your state’s patient advocacy group. They will help you get what you need and deserve.
5.    Most critical of all, do not concede. Patients who fight for their rights tend to win. You have the loudest, most meaningful and persuasive voices. Do not be afraid to use them.